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Immune Responses to Yellow Fever Vaccine

This study is currently recruiting participants.
Verified September 2017 by Sri Edupuganti, MD MPH, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01244802
First Posted: November 19, 2010
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
  Purpose
The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.

Condition
Yellow Fever Vaccine

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

Resource links provided by NLM:


Further study details as provided by Sri Edupuganti, MD MPH, Emory University:

Primary Outcome Measures:
  • Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination [ Time Frame: Immune responses will be measured from at least 30 days after yellow fever vaccination. ]
    This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.


Biospecimen Retention:   Samples With DNA
Blood

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1: 18 to 45 years of age
Between the ages of 18 and 45 at the time of yellow fever vaccination
Group 2: 55 years of age and above
Aged 55 or greater at the time of yellow fever vaccination

Detailed Description:

The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.

The specific aims of the study are to:

  • Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination
  • Determine neutralizing antibody titer after yellow fever vaccination
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine
Criteria

Inclusion Criteria:

  • Able to understand and give informed consent
  • Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination
  • Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.

Exclusion Criteria:

  • Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)
  • History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)
  • Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form
  • Recipient of a blood product or immune globulin product within 42 days of study visit
  • Reporting pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244802


Contacts
Contact: Shashi Nagar, RN 404-712-1370 shashi.nagar@emory.edu

Locations
United States, Georgia
The Hope clinic of Emory Vaccine Center Recruiting
Decatur, Georgia, United States, 30030
Contact: Sashi Nagar       shashi.nagar@emory.edu   
Principal Investigator: Srilatha Edupuganti, MD         
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
Investigators
Study Director: Rafi Ahmed, PhD Emory University
Principal Investigator: Srilatha Edupuganti, MD Emory University
  More Information

Responsible Party: Sri Edupuganti, MD MPH, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01244802     History of Changes
Other Study ID Numbers: IRB00002834
YFV-2 Cross sectional ( Other Identifier: Other )
5U19AI057266 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2010
First Posted: November 19, 2010
Last Update Posted: September 22, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sri Edupuganti, MD MPH, Emory University:
yellow fever vaccine

Additional relevant MeSH terms:
Fever
Yellow Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs